Thoughtful planning and preparation are required for successfully managing inspections by regulatory health authorities to reduce the risk of regulatory enforcement actions. Our team of industry experts and former FDA consumer safety officers has the knowledge and experience to develop tailored inspection readiness plans and can support your staff to prepare for positive interactions with inspectors from around the world.
Pharmatech’s approach of achieving Compliance Through Science®, i.e. employing objective evidence to demonstrate compliance, is directly aligned with the global health authority (e.g. FDA) requirements for quality and product predictability. Our plans are effective, efficient, and capable of demonstrating to the agency that you have a sustainable and fully compliant system.
Our unique approach can help your company navigate the complexities of launching a drug, biologic or medical device into multiple markets. The first step? Connecting. Simply fill out our form and a representative will follow-up shortly.
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